Arena Seeks European Union Approval for Obesity Drug Lorcaserin

Monday, March 5, 2012

San Diego-based Arena Pharmaceuticals Inc. on March 2 said it’s seeking regulatory approval to sell its investigational weight-loss drug lorcaserin in the European Union.

The company filed a Marketing Authorization Application with the European Medicines Agency. Arena said it expects the agency will accept the filing later this month and then move forward with a substantive review.

“With rates of obesity tripling in many European countries over the last 30 years, there is a substantial unmet need for new treatments to manage weight,” Arena President and CEO Jack Lief said in a statement.

Arena’s drug is still pending approval in the U.S. The company resubmitted lorcaserin to the Food and Drug Administration in December. The FDA accepted the submission and assigned a target decision date of June 27.

Eisai Inc., a Woodcliff Lake, N.J., pharmaceutical company, has exclusive rights to market and distribute lorcaserin in the U.S. subject to FDA approval, but Arena currently owns rights to lorcaserin outside of the United States. There was no word on potential partnerships.

Lorcaserin is intended for weight control in patients who are obese or overweight and have at least one weight-related health condition. It is Arena’s most advanced investigational drug candidate, having already gone through two phase 3 clinical trials.

Unlike other obesity drug candidates pending FDA approval that are combinations of existing drugs — such as the investigational drug Contrave, from San Diego-based Orexigen Therapeutics Inc., which is a combination of bupropion and naltrexone — lorcaserin is an entirely new chemical entity that works with the area of the brain that controls appetite and metabolism.

Arena shares were up slightly on Nasdaq the morning of March 2, trading at $1.83.